Education and Training
CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma
The purpose of this study is to find out if giving a dose of heated chemotherapy in the abdomen immediately after surgery that is done to remove uterine leiomyosarcoma type of cancer will help lower the risk of the cancer coming back in the future.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Gemcitabine
- drug: Dacarbazine
- procedure: Cytoreductive Surgery
- behavioral: Functional Assessment of Cancer Therapy (FACT) G questionnaire
- procedure: Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan
- drug: Gadolinium
Eligibility
Inclusion Criteria:
1. Histologically confirmed diagnosis of uterine leiomyosarcoma (LMS) with evidence of
local recurrence.
2. Imaging provides evidence of locally recurrent uterine LMS.
3. Candidate for potentially radical, maximal effort cytoreductive surgery at the
discretion and expertise of the treating physician.
4. Age ≥ 18 years.
5. Life expectancy > 3 months.
6. Women of childbearing potential (WOCBP) will have a negative pregnancy test ≤ 7 days
prior to surgery (this test can be omitted if subject is post menopausal by either
surgery or elevated FSH)
7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
8. Hemoglobin (HGB) ≥ 9 g/dL.
9. White blood cell count (WBC) ≥ 3.0 K/ul.
10. Absolute neutrophil count (ANC) ≥ 1.5 K/ul.
11. Platelets (PLT) ≥ 100 K/ul.
12. Total bilirubin within normal institutional limits.
13. Serum glutamic oxaloacetic transaminase (SGOT/Serum glutamic pyruvic transaminase
(SGPT) < 2.5 x institutional upper limit of normal (ULN).
14. Creatinine < 1.5 x ULN or creatinine clearance > 60 mL/min according to Cockroft Gault
formula.
15. Prothrombin Time (PT) such that international normalized ratio (INR) is < 1.5 (or an
in range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic
warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) <
1.2 times control.
16. Serum albumin ≥ 2.5 g/dL.
17. Ability to understand and the willingness to personally sign the written IRB approved
informed consent document.
Note that this study does not allow the use of a legally authorized representative
Exclusion Criteria:
1. Recurrence of LMS within less than 6 months after the last dose of gemcitabine.
2. Active extra abdominal disease including active malignant pleural effusion. Subjects
who have been successfully treated with neoadjuvant chemotherapy and no longer have
(malignant) pleural effusions may be included.
3. Prior gemcitabine given in non adjuvant setting.
4. Prior treatment with dacarbazine.
5. Active infection requiring antibiotics.
6. Unresolved toxic effects of prior therapy (except alopecia). Resolution is considered
≤ Grade 1 per NCI CTCAE, version 5.0.
7. Pregnant.
8. Breast feeding.
9. Presence of metastatic liver disease
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
Female
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ghazal Jawed
gjawed@stanford.edu
Not Recruiting